Agency classClass IIOur severity:Severe FDA (Drugs)·D-1658-2015·Announced 2015-09-23

Testosterone and Anastrazole Pellets Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 1 mg Pellets due to FDA inspection findings of GMP violations that may impact sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in injectable/implantable products where infection risk is a significant concern.

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 1 mg Pellets, Sterile. The product is distributed nationwide and consists of 10 pellets per unit. The recall covers all lots distributed between November 2014 and May 2015, including lot 03162015@38.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency classifies this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased these pellets should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal. The recall number is D-1658-2015.

The recalled product

Product: Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Pellets
Hazard: sterility
gmp-violation
Affected units: 10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

All lots distributed between November 2014 and May 2015
03162015@38
9/12/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility